For Aperio Clinical Outcomes, honest communication and quality data are the foundation to forming long-term relationships with their clients. Headquartered in Durham, NC, this clinical research organization (CRO) provides sponsors with customizable clinical development, quality assurance, and trial technology services for drugs and medical devices across multiple therapeutic areas.
As a growing CRO, Aperio was ready to make the move to an electronic quality management system (eQMS) after finding their in-house solution inefficient at keeping track of the company’s training and documentation records. “Managing our Quality documents —SOPs, policies, etc.— was a manual, time consuming process and we were unable to scale with the rapid growth we were experiencing. To finalize a document, we’d use one system to sign, we’d send updates via Outlook, put training in another system, and update three trackers along the way,” said Blair Covington, Aperio’s Associate GCP Auditor. “We were looking for a solution that would streamline the process of maintaining our Quality documents and roll them out for training.”
After researching and demo-ing a few different eQMS solutions, Aperio ultimately chose ZenQMS because they found it easy to use and the platform aligned with their current processes. “There was structure,” said Blair, “but we also had room for customization without being overwhelmed at having to build the entire system ourselves.”
Their implementation and document migration process into ZenQMS was going smoothly, with Blair enjoying some of the quickest customer support response times she’d ever experienced. “[ZenQMS Project Manager] Nathan was awesome. I’d send him a document, and three minutes later he’d have it uploaded.” Unfortunately, Aperio was forced to delay go-live with ZenQMS due to competing priorities. When things quieted down a few months later, they were able to quickly and painlessly reimplement with help from ZenQMS’ support team once again.
“It worked out well,” said Aperio’s Director of eClinical Technologies, Melissa Hancock. “I was pleased that we didn’t have to manually re-import documents when we had to restart. We were able to re-import everything automatically, and it was all good.”
Not only was Aperio’s transition to ZenQMS made easy because of dedicated in-house support, but they received further assistance in the form of helpful training videos designed to make the implementation process even easier. “The training we received during implementation was very robust. The videos were easy to navigate and get through,” said Blair.
Aperio was happy to find that ZenQMS’ implementation process matched their own company values of transparency and honesty. “We’re not in an escape room trying to solve a puzzle,” said Melissa, who is in charge of implementing the software programs for Aperio. “Part of being on the implementation team is being able to train others in the future. I felt like I had everything I needed. It wasn’t a secret. I never felt like I needed to get the key to unlock the door in order to get all the information. It was just all there and available.”
In Melissa’s 25 years of working in clinical research and technology, she recognizes that ZenQMS’ approach to implementation and support is unique. Many software systems provide a manual and not much else. And in cases where companies do provide e-learning, Melissa has not been impressed with what’s been available to the admin teams. “Most of what I see in the industry is for end-users, not implementation teams. So as far as that goes, you’re sort of at the whim of the consultant to teach you how to use it. ZenQMS gives the eLearnings and documentation to the actual implementation team as opposed to the end-user side. We were also working after core hours, so being able to watch the videos on our own time for refreshers was helpful.”
Melissa continued, “You guys did a great job of blending eLearning and support in little chunks that we could consume at our own pace. And the Sandbox was super helpful. It was nice to be able to focus and not be overwhelmed.”
If you’re looking to implement an eQMS quickly and easily, with plenty of support, schedule a demo with ZenQMS.